The National Agency for Food and Drug Administration and Control (NAFDAC) has alerting the public about the illegal sale and distribution of an unregistered brand of condoms in Nigeria: Foula Condoms.
A statement posted at the official website of NAFDAC, disclosed that officials from the Post-Marketing Surveillance (PMS) directorate discovered Foula condoms (packaged in threes) in Abakaliki, Ebonyi State, and Zango, Katsina State.
NAFDAC revealed that the discovery was made during a Risk-Based Post Marketing Surveillance study on registered condoms in Nigeria.
The agency explained that the condom is not registered by NAFDAC for use in Nigeria, and the labeling of the product is not in English Language.
NAFDAC stated that ondoms are a proven effective barrier method that can be used as a dual-purpose method for both prevention of unintended pregnancy and protection against HIV and other sexually transmitted infections (STIs). To be most effective, any barrier method used for contraception or preventing infection must be used correctly.
RISK
The illegal distribution or sale of unregistered condoms poses a risk as the safety, quality, and efficacy of the products are not guaranteed. The purchase and use of poor-quality condoms will adversely affect every aspect of condom promotion for the prevention of unintended pregnancy and protection against HIV and other Sexually Transmitted Infections. If condoms leak or break, they cannot offer adequate protection.
PRODUCT DETAILS
The details of the falsified Condoms are as follows.
Product Name
Foula condoms
Produit par
(Produced by)
Guilin Zizhu Latex Co., Ltd. No. 6 Wushan Road Guilin, 541001, P.R. de China
Pour le compte de
(On behalf of)
Sanavita Pharmaceuticals Gmbh, Spaldingstr. 110B, 20097 Hambourg, Republic Federale d’ Allemagne (Republic of Germany)
Importe par (Imported by)
Project Marketing Social / ANIMAS-SUTURA, Quartier Recasement, derriere la maternite Yantala, B.P. 11738, Niamey, Niger
Lot No.
2184070
Date de production (Product date)
08/2022
Date of peremption (Expiration date)
07/2027
Labelling
The labeling on the pack of the product is not in English Language.
NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the unregistered products within the zones and states.
Importers, distributors, retailers, healthcare professionals, and consumers are hereby advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of illegally distributed products. All medical products/ medical devices must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med- safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).